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Cell/Tissue Product eSubmission Instructions

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CBER posts Instructions for Using the Electronic Human Cell and Tissue Establishment Registration System (eHCTERS).

8 FDA Info Collections Gain OMB Approval

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Federal Register notice: FDA posts a list of eight information collections that have been approved by OMB.

CDER Office of New Drugs Reorganization in Phase 2

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CDER says reorganization of the Office of New Drugs moved into Phase 2 11/4.

Innoveix FDA-483 Released

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FDA releases an FDA-483 with seven observations issued following an inspection at Innoveix Pharmaceuticals.

Pfizer Sees Rebate Issue Blocking Biosimilar Use

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Biopharma Reporter says that Pfizer CEO Albert Bourta is leading the effort to reform drug company rebates to payers that he says ...

Recommendations for Neonatal Pharmacology Guidance

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Four stakeholders praise and recommend changes to an FDA draft guidance on general clinical pharmacology considerations for neonat...

CDER Office of Hematology, Oncology Products Reorganized

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CDER has completed reorganization of the Office of Hematology and Oncology Products into the Office of Oncologic Diseases.

Safety Surveillance Best Practices Draft

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FDA posts for comment a draft document with best practices for agency staff in conducting postmarket safety surveillance of drugs ...

Senate Sets 11/20 FDA Confirmation Hearing

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The Senate Health, Education, Labor & Pensions Committee schedules an 11/20 confirmation hearing for FDA commissioner nominee Step...

Sandoz Neulasta Biosimilar Approved

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FDA approves Sandozs Ziextenzo (pegfilgrastim-bmez), a biosimilar to Amgens Neulasta (pegfilgrastim).